Humeral Nail System Cleared in Under 30 Days

The FDA just cleared Orthopedic Designs North America, Inc.’s humeral nail in under 30 days. The agency received the clearance request on January 26, 2018 and notified the company on February 22, 2018.

According to the FDA filings, “the Talon DistalFix Humeral Nail system is indicated to aid in the alignment and stabilization of humeral fractures, including:

• Diaphyseal fractures of the humeral shaft
• Proximal humeral fractures with diaphyseal extension
• Impending pathologic fractures”

The company says the device eliminates the need for freehand drilling and distal locking screws, resulting in less operative time, elimination of stress risers, fewer incisions, reduced radiation exposure and decreased operating room expenses.

Talon DistalFix Parts

The system, according to FDA documents, consists of the following parts:

1. “A humeral nail with proximal portals for passage of cortical locking screws and distal portals that allow passage of deployable integral talons to achieve distal fixation from within the intramedullary canal. The distal talons may be retracted for removal of the intramedullary nail if and when it is necessary. The nail will be provided in a pre-assembled condition with the deployable distal nail talons and distal end cap already installed.
2. Cortical locking screws will be provided separately. The cortical locking screws have a reduced minor diameter at the tip which provides increased purchase in cancellous bone by increasing the thread height and are provided for proximal fixation if desired.
3. A proximal end cap will be provided separately. The end cap prevents bony ingrowth and preserves the threads which may be used for attachment of instrumentation during explantation of the nail.”

The predicate device for comparison was the Synthes Titanium Cannulated Humeral Nail Expert System.